The FDA is reviewing roflumilast 0.05% cream for atopic dermatitis in infants as young as 3 months, while the 0.3% formulation just got approved for plaque psoriasis in children down to age 2. Together, these moves signal a major expansion of steroid-free topical options for the littlest patients. A decision on the infant eczema indication is expected by February 2027.
The FDA has accepted a supplemental NDA for roflumilast 0.05% cream (Zoryve) to treat mild-to-moderate atopic dermatitis (AD) in infants aged 3–24 months — the youngest age group yet for this drug. Currently approved for AD in children 2 years and older, the expanded indication is backed by phase 1 and 2 open-label studies in 101 infants, with a PDUFA action date of February 23, 2027.
Meanwhile, the FDA separately approved roflumilast 0.3% cream for plaque psoriasis in children as young as 2 years on June 30, 2026 — the first steroid-free prescription topical for this age group. The approval was supported by a 4-week MUSE study and a 24-week open-label extension, with safety and efficacy consistent with adult and adolescent data.
By the Numbers:
Why it matters: Infants with eczema and toddlers with psoriasis have had very limited steroid-free treatment options. These developments could reshape how clinicians manage inflammatory skin disease in the youngest and most vulnerable patients.
